Could a zapping the gut help beat immunotherapy resistance?
NCT ID NCT07071103
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a low dose of radiation to the small intestine can help the immune system fight cancers that have stopped responding to immunotherapy. About 48 adults with advanced lung, esophageal, or other solid tumors will receive one radiation session followed by continued immunotherapy. Researchers will track tumor shrinkage, side effects, and changes in gut bacteria to see if this approach can restore treatment effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-dose radiation to the intestine and PD-1/PD-L1 inhibitors
- What this could lead to
- If it works, this could offer a new treatment option for people whose cancers have stopped responding to immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 48 participants, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years, ≤80 years, regardless of gender. * ECOG level 0-2. * Expected life span\>3 months. * At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria. * Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression. * Patients should not be considered eligible for surgical treatment. * Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and/or MRI scans are eligible. * Patients have complete clinical and pathological information. * Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol. * Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form. * Other indicators accord with the general inclusion criteria for clinical trials. Exclusion Criteria: * Patients with contraindications to radiation therapy and immunotherapy. * Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.). * Patients who were assessed as hyperprogressive disease (HPD). * Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment. * The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss). * Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment. * Significant liver or kidney dysfunction (i.e., laboratory values \>3 times the upper limit of normal). * Active hepatitis B, hepatitis C, HIV, or syphilis. * Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function. * Hypersensitivity to any drug included in the trial. * Drug and/or alcohol abuse. * Pregnant or breastfeeding women. * Concurrent participation in another therapeutic clinical trial. * Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention). * Major surgery within 30 days. * Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital, Shantou University Medical College
RECRUITINGShantou, Guangdong, 515031, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Tiny gadolinium particles aim to make brain radiation hit harder
- Can a Butter-Derived supplement protect the gut during cancer radiation?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a needle at the knee supercharge lung cancer immunotherapy?